115 results on '"Smalling, R. W."'
Search Results
2. Intravascular photoacoustic imaging of atherosclerotic plaques: ex-vivo study using a rabbit model of atherosclerosis.
- Author
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Sethuraman, S., Mallidi, S., Aglyamov, S. R., Amirian, J. H., Litovsky, S., Smalling, R. W., and Emelianov, S. Y.
- Published
- 2007
- Full Text
- View/download PDF
3. Development of a combined intravascular ultrasound and photoacoustic imaging system.
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Sethuraman, S., Aglyamov, S. R., Amirian, J. H., Smalling, R. W., and Emelianov, S. Y.
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- 2006
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4. Size Effects in Abrasive Processes.
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Malkin, S., Wiggins, K. L., Osman, M., and Smalling, R. W.
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- 1973
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5. Final results of the Can Routine Ultrasound Influence Stent Expansion (CRUISE) study.
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Fitzgerald, P J, Oshima, A, Hayase, M, Metz, J A, Bailey, S R, Baim, D S, Cleman, M W, Deutsch, E, Diver, D J, Leon, M B, Moses, J W, Oesterle, S N, Overlie, P A, Pepine, C J, Safian, R D, Shani, J, Simonton, C A, Smalling, R W, Teirstein, P S, and Zidar, J P
- Published
- 2000
6. Therapy with thrombolytic agents in coronary artery disease.
- Author
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Hanna, G P and Smalling, R W
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- 1998
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7. Clinical trial results with a new plasminogen activator.
- Author
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Bode, C., Peter, K., Moser, M., Smalling, R. W., and Weaver, W. D.
- Abstract
Thrombolysis has become an accepted form of therapy for acute myocardial infarction. As demonstrated in the Global Utilization of Streptokinase and t-PA for Occluded Arteries trial, early, complete and sustained patency of the infarctrelated coronary artery is correlated with reduced mortality. However, current thrombolytic regimens are able to achieve such patency within 90 min in only 81% of cases. To improve the risk/benefit ratio of thrombolytic therapy, newer agents such as reteplase have been developed to establish more rapid, more complete and more stable coronary artery patency, thus reducing mortality.This report summarizes the pharmacological properties of reteplase. It also summarizes the findings from various animal and clinical studies in which reteplase was compared with alteplase and streptokinase and the findings from animal and clinical studies evaluating infusion, single-bolus, and double-bolus doses of reteplase. [ABSTRACT FROM PUBLISHER]
- Published
- 1997
- Full Text
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8. Pharmacological and clinical impact of the unique molecular structure of a new plasminogen activator.
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Smalling, R. W.
- Abstract
Thrombolytic therapy has been recognized as a significant improvement in the management of acute myocardial infarction. Thrombolytic agents however have been limited by short half-lives that necessitate complex administration protocols and by the potential for bleeding complications.The native t-PA molecule has since been modified in an attempt to achieve improved lytic characteristics with less risk of bleeding.Reteplase is a third-generation recombinant mutant of tissue-type plasminogen activator (t-PA) that is expressed in Escherichia coli cells and consists of the kringle 2 and the protease domains of t-PA. Compared with t-PA, reteplase has a lower fibrin binding, which may translate to improved clot penetration. As well as a longer half-life and a more rapid initiation of thrombolysis. Preclinical pharmacology studies have indicated that reteplase has potent in vivo thrombolytic activity and leads to rapid reperfusion; these findings have been confirmed by promising results obtained in large-scale clinical trials.Other new agents developed by modifying the native t-PA molecule include the n-PA and the TNK mutants of t-PA. These novel, genetically modified thrombolytic agents all lyse clots better than the native t-PA; however, they differ with respect to their half-lives and fibrin-binding activity.Although all the third-generation thrombolytic agents have shown considerable potential in improving the efficacy of thrombolytic therapy, their risk of intracranial bleeding remains problematic and is still somewhat uncertain. [ABSTRACT FROM PUBLISHER]
- Published
- 1997
- Full Text
- View/download PDF
9. The future of thrombolysis in the treatment of acute myocardial infarction.
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Bode, C., Runge, M. S., and Smalling, R. W.
- Abstract
The ability of thrombolytic therapy to lower mortality in patients with acute myocardial infarction was first demonstrated in 1986 by the Gruppo Italiano per lo Studio della Streptochinasi nell'lnfarto Miocardico. In the ensuing 10 years, large efforts have been undertaken to develop more effective and safer thrombolytic agents. In addition, the value of adjunctive agents influencing thrombotic and thrombolytic processes was demonstrated, and newer agents are under active investigation. This review focuses on theoretical and practical aspects of optimizing thrombolytic therapy and on genetically engineered third generation plasminogen activators. Optimized thrombolytic therapy may make this form of therapy available to patients who are currently considered ineligible, and it will lead to earlier, more complete reperfusion of infarct-related coronary arteries. The benefits and risks of optimized thrombolytic regimens relative to those of mechanical reperfusion strat egies will require constant reassessment while both forms of treatment develop. [ABSTRACT FROM PUBLISHER]
- Published
- 1996
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10. Coronary artery flow monitoring: The value of intravascular Doppler for detection of complications after interventions.
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Anderson, H. V., Kirkeeide, R. L., Willerson, J. T., Smalling, R. W., and Schroth, G.
- Abstract
Ultrasound transducer-tipped guidewires can be used for coronary interventions, and they permit the monitoring of coronary flow before during, and after the interventions. The flow signal contains valuable information regarding the quality and stability of the final result. Restoration of typical phasic flow patterns with diastolic predominance is one guide to final result. Monitoring the trend in average velocity over several minutes after completion of the procedure can detect subtle alterations in flow that may presage abrupt closure. These flow alterations might also help predict active plaques with heavy thrombus involvement that may undergo recurrence in the weeks and months after successful procedures. [ABSTRACT FROM PUBLISHER]
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- 1995
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11. Risk/Benefit Analysis of Intracoronary Thrombolytic Therapy in Evolving Myocardial Infarction.
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Smalling, R. W., Fuentes, F. F., Hicks, C., Matthews, M. W., Kuhn, J., Freund, G. C., and Gould, K. L.
- Abstract
Intracoronary streptokinase administration during acute myocardial infarction is a time-consuming and potentially dangerous technique. However, it does appear to be beneficial in terms of reduced mortality and improved left ventricular function. We have prospectively studied 258 patients with acute myocardial infarction of whom 180 were subjected to acute cardiac catheterisation and intracoronary streptokinase administration. The remaining 78 either refused the protocol or met exclusion criteria and were studied prospectively as a control group. Patients with anterior myocardial infarction demonstrated a most profound improvement in both mortality and myocardial function with intracoronary thrombolytic therapy. Patients with inferior myocardial infarction demonstrated an improvement in left ventricular function with successful coronary reperfusion, but did not achieve a statistically significant improvement in mortality compared to controls. Time from onset of pain to reperfusion up to 18 h after onset of pain did not affect improvement in left ventricular function or survival. Patients more than 65 years of age did not show a difference in survival when treated with thrombolytic therapy compared with controls of similar age group. However, patients less than 65 years of age treated with intracoronary streptokinase therapy demonstrated a mortality of 4% compared to 18% in similar controls. Two patients may have died as a direct result of intracoronary thrombolytic therapy, but no patients died as a result of bleeding complications. Thus, the most striking results with intracoronary thrombolytic therapy during evolving myocardial infarction are seen in patients with anterior myocardial who are less than 65 years of age. Time from onset of pain to reperfusion and presence of Q waves on initial electrocardiogram do not affect the observed outcome of this intervention. [ABSTRACT FROM PUBLISHER]
- Published
- 1985
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12. Transvalvular left ventricular assistance in acute myocardial infarction with cardiogenic shock and high risk angioplasty: experimental and clinical results with the Hemopump.
- Author
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SMALLING, RICHARD W. and Smalling, R W
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- 1995
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13. Streptokinase reperfusion and early surgical revascularization in patients with acute myocardial infarction.
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WALKER, WILLIAM E., SMALLING, RICHARD W., STERLING, ROSALYN P., DuBOSE, RALPH K., FUENTES, FRANCISCO, REDUTO, LAWRENCE A., GOULD, K. LANCE, Walker, W E, Smalling, R W, Sterling, R P, DuBose, R K, Fuentes, F, Reduto, L A, and Gould, K L
- Published
- 1982
14. Recording Skin Resistance and Beat-By-Beat Heart Rate From the Same Pair of Dry Electrodes.
- Author
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Geddes, L. A., D., Bourland, J., Smalling, R. W., and Steinberg, R. B.
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SKIN ,ELECTROCARDIOGRAPHY ,HEART beat ,ELECTRODES ,PSYCHOPHYSIOLOGY ,SILVER - Abstract
Changes in skin resistance and beat-by-beat heart rate, derived from the EKG, were obtained from the same pair of dry silver electrodes applied to the finger tips. The electronic criteria to be satisfied for application of this technique are discussed. The recording system was constructed using low-cost, solid-state circuitry. A typical record of changes in skin resistance and beat-by-beat heart rate is presented to demonstrate the performance characteristics of the equipment. [ABSTRACT FROM AUTHOR]
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- 1974
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15. Coronary artery flow monitoring following coronary interventions.
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Anderson, H. V., Kirkeeide, R. L., Willerson, J. T., Mishkel, D. C., Kjellgren, O., Smalling, R. W., and Schroth, G.
- Abstract
Coronary guidewires with ultrasound transducer tips are commercially available and are appropriately sized for use in coronary interventions. These guidewires permit monitoring of coronary flow before, during and after the interventions. The measured flow signal contains valuable information regarding the quality and the stability of the final result. After completion of the procedure, monitoring the trend in average velocity over several minutes can reveal subtle alterations in flow that may presage abrupt closure. Abnormal or unstable flow patterns also may help predict lesions that might develop recurrences in the weeks and months after successful procedures. [ABSTRACT FROM PUBLISHER]
- Published
- 1995
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16. Rotational aortogram with three-dimensional reconstruction in a case of repaired aortic coarctation.
- Author
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Boccalandro, F, De La Guardia, B, and Smalling, R W
- Published
- 2001
17. Causes of early reintervention after successful coronary artery stenting.
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Assali, Abid R., Sdringola, Stefano, Assali, A R, Sdringola, S, Ghani, M, Moustapha, A, Anderson, H V, Schroth, G, Fujise, K, Smalling, R W, and Rosales, O
- Subjects
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CORONARY artery surgery , *SURGICAL stents - Abstract
Acute reintervention was performed in 26 of 1,620 patients after coronary stenting (1.6%). Half of the patients had stent thrombosis and the other half residual anatomic problems. The mean time for reintervention was shorter in patients with stent thrombosis. All patients with stent thrombosis had a sudden recurrence of chest pain. Electrocardiographic changes were more common with stent thrombosis. Composite end point occurred in 10 patients (77%) with stent thrombosis versus 5 (39%) in the other group (p = 0.04). [ABSTRACT FROM AUTHOR]
- Published
- 2000
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18. Clinical experience with the percutaneous hemopump during high-risk coronary angioplasty.
- Author
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Scholz, Karl H., Urban, Philip, Scholz, K H, Dubois-Rande, J L, Urban, P, Morice, M C, Loisance, D, Smalling, R W, and Figulla, H R
- Subjects
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ANGIOPLASTY , *CORONARY disease , *ARTIFICIAL implants , *PATIENTS - Abstract
The percutaneous Hemopump showed beneficial effects during coronary angioplasty in 32 high-risk patients with unloading of the left ventricle during ischemia and maintaining cardiac output with mean aortic pressures of 50 mm Hg in case of cardiac arrest (3 patients). High procedure-related morbidity (occlusion of femoral artery in 2 patients; bleeding with need of transfusion in 4 patients) and mortality (4 of 32 patients) rates demonstrate the need for a very careful selection of patients. [ABSTRACT FROM AUTHOR]
- Published
- 1998
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19. Risk assessment of slow or no-reflow phenomenon in aortocoronary vein graft percutaneous intervention.
- Author
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Sdringola S, Assali AR, Ghani M, Moustapha A, Achour H, Yusuf SW, Fujise K, Rosales O, Schroth GW, Anderson HV, and Smalling RW
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- Aged, Female, Humans, Male, Middle Aged, Multivariate Analysis, Predictive Value of Tests, Risk Assessment, Stents, Texas, Treatment Outcome, Aorta surgery, Coronary Artery Bypass instrumentation, Coronary Vessels surgery, Saphenous Vein surgery
- Abstract
Slow or no-reflow phenomenon (SNR) complicates 10%-15% of cases of percutaneous intervention (PCI) in aortocoronary saphenous vein grafts (SVG). At present, there are no uniform, effective strategies to predict or prevent this common and potentially serious complication. The purpose of our study was to characterize variables correlated with the risk of SNR in SVG PCI in the era of stenting and glycoprotein IIb/IIIa receptor inhibitors. We identified 2,898 consecutive patients who had PCI, of whom 163 underwent PCI of at least one SVG. The clinical and angiographic characteristics of patients who developed SNR (SNR group) were compared with those who did not (no-SNR group). A total of 23 patients experienced SNR and 140 did not. Using a stepwise multivariate logistic regression analysis, four independent predictors for SNR were detected: probable thrombus (OR 6.9; 95% CI, 2.1-23.9; P = 0.001), acute coronary syndromes (OR 6.4; 95% CI, 2.0-25.3; P = 0.003), degenerated vein graft (OR 5.2; 95% CI, 1.7-16.6; P = 0.003), and ulcer (OR 3.4; 95% CI, 0.99-11.6; P = 0.04). The risk of developing SNR could be estimated according to the number of predictors found: low-grade risk (1%-10%) if < or = one variable was present, moderate risk (20%-40%) if two variables were present, and high risk (60%-90%) if three or more variables were present. We identified and quantified current risk factors for SNR and concluded that the risk of developing SNR during PCI in SVG can be predicted by simple clinical and angiographic variables obtained before PCI. This information may be useful when the risk of PCI has to be balanced against alternative strategies such as medical therapy or redo-bypass surgery or in the selection of those patients that will most benefit from the use of protection devices during PCI., (Copyright 2001 Wiley-Liss, Inc.)
- Published
- 2001
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20. Effects of clopidogrel pretreatment before percutaneous coronary intervention in patients treated with glycoprotein IIb/IIIa inhibitors (abciximab or tirofiban).
- Author
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Assali AR, Salloum J, Sdringola S, Moustapha A, Ghani M, Hale S, Schroth G, Fujise K, Anderson HV, Smalling RW, and Rosales OR
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- Abciximab, Aged, Clopidogrel, Coronary Disease drug therapy, Female, Humans, Male, Middle Aged, Tirofiban, Treatment Outcome, Angioplasty, Balloon, Coronary, Antibodies, Monoclonal therapeutic use, Coronary Disease therapy, Immunoglobulin Fab Fragments therapeutic use, Platelet Aggregation Inhibitors therapeutic use, Platelet Glycoprotein GPIIb-IIIa Complex antagonists & inhibitors, Stents, Ticlopidine analogs & derivatives, Ticlopidine therapeutic use, Tyrosine analogs & derivatives, Tyrosine therapeutic use
- Published
- 2001
- Full Text
- View/download PDF
21. Percutaneous intervention in saphenous venous grafts: in-stent restenosis lesions are safer than de novo lesions.
- Author
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Assali AR, Sdringola S, Moustapha A, Ghani M, Achour H, Hale S, Schroth G, Fujise K, Anderson HV, Smalling RW, and Rosales OR
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- Aged, Coronary Artery Bypass, Female, Graft Occlusion, Vascular surgery, Humans, Male, Middle Aged, Myocardial Infarction etiology, Postoperative Complications, Stents, Treatment Outcome, Angioplasty, Balloon, Coronary, Saphenous Vein transplantation
- Abstract
Background: The histological appearance of stenosis in de novo saphenous venous grafts (DNSVG) consists of diffuse atherosclerosis that contains blood elements, necrotic debris and limited fibrocollagenous tissue. The friable nature of these lesions complicates percutaneous intervention (PCI) procedures. On the other hand, in-stent restenosis (ISR) of SVG is due primarily to atherosclerotic plaque or fibromuscular hyperplasia, with thrombus formation playing a secondary role. The purpose of this study is to compare the results of PCI in these two types of SVG lesions., Methods: We reviewed our institutional interventional database from March 1996 through February 2000 and identified all consecutive patients who underwent PCI of at least one SVG. One hundred and ten patients were identified: 89 undergoing DNSVG intervention and 21 patients with ISR lesions., Results: Acute coronary syndromes, degenerated and thrombus-containing lesions were more common in the DNSVG group. "Slow-, no-reflow" complicated 20% of the DNSVG lesions compared to none of the ISR lesions (p = 0.02). Post-procedural myocardial infarction was higher in the DNSVG group (13.5% versus 0%; p = 0.1) and correlated significantly with the occurrence of "slow-, no-reflow" (r = 0.43; p = 0.0001). Utilizing statistical modeling to adjust for baseline differences between the groups, ISR lesions were associated with a low risk of procedural complications (r = 0.22; p = 0.03)., Conclusion: This study demonstrates that in this relatively high-risk population, PCI is safer in ISR lesions than in de novo SVG lesions.
- Published
- 2001
22. Endovascular repair of traumatic pseudoaneurysm by uncovered self-expandable stenting with or without transstent coiling of the aneurysm cavity.
- Author
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Assali AR, Sdringola S, Moustapha A, Rihner M, Denktas AE, Lefkowitz MA, Campbell M, and Smalling RW
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- Adult, Cardiovascular Surgical Procedures, Humans, Male, Vascular Diseases surgery, Vascular Diseases therapy, Aneurysm, False therapy, Coronary Aneurysm therapy, Embolization, Therapeutic, Stents
- Abstract
Various surgical options for internal carotid or subclavian artery pseudoaneurysm repair have been reported; however, in general they have resulted in poor outcomes with high morbidity and mortality rates. Recently, these open surgical procedures have been partly replaced by percutaneous transluminal placement of endovascular devices. We evaluated the potential for using flexible self-expanding uncovered stents with or without coiling to treat extracranial internal carotid, subclavian and other peripheral artery posttraumatic pseudoaneurysm. Three patients with posttraumatic pseudoaneurysm were treated by stent deployment and coiling (two cases) of the aneurysm cavity. In one case, a 5.0 x 47 mm Wallstent (Boston Scientific) was positioned to span the neck of the 9 x 5 mm size pseudoaneurysm (left internal carotid artery) and deployed. Angiography demonstrated complete occlusion of the pseudoaneurysm without coiling. In the second patient, a 5.0 x 31 mm Wallstent (Boston Scientific) was positioned to span the neck of the 9 x 7 mm size pseudoaneurysm (right internal carotid artery) and deployed. A total of six coils (Guglielmi Detachable Coils, Boston Scientific) were deployed into the pseudoaneurysm cavity until it was completely obliterated. In the third case, an 8.0 x 80 mm SMART (Cordis) stent was advanced over the wire, positioned to span the neck of the 10 x 7 mm size pseudoaneurysm of the left subclavian artery, and deployed. Fourteen 40 x 0.5 mm Trufill (Cordis) pushable coils were deployed into the pseudoaneurysm cavity until it was completely obliterated. At long-term follow-up (6-9 months), all patients were asymptomatic without flow into the aneurysm cavity by Duplex ultrasound. We conclude that uncovered endovascular flexible self-expanding stent placement with transstent coil embolization of the pseudoaneurysm cavity is a promising new technique to treat posttraumatic pseudoaneurysm vascular disease by minimally invasive methods, while preserving the patency of the vessel and side branches.
- Published
- 2001
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23. Percutaneous and surgical interventions for in-stent restenosis: long-term outcomes and effect of diabetes mellitus.
- Author
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Moustapha A, Assali AR, Sdringola S, Vaughn WK, Fish RD, Rosales O, Schroth G, Krajcer Z, Smalling RW, and Anderson HV
- Subjects
- Angioplasty, Balloon, Coronary, Atherectomy, Coronary, Coronary Artery Bypass, Female, Humans, Male, Middle Aged, Recurrence, Time Factors, Treatment Outcome, Coronary Disease complications, Coronary Disease surgery, Diabetes Complications, Stents
- Abstract
Objective: We examined long-term outcomes of patients with in-stent restenosis (ISR) who underwent different percutaneous interventions at the discretion of individual operators: balloon angioplasty (BA), repeat stent or rotational atherectomy (RA). We also examined long-term outcomes of patients with ISR who underwent coronary artery bypass surgery (CABG)., Background: In-stent restenosis remains a challenging problem, and its optimal management is still unknown., Methods: Symptomatic patients (n = 510) with ISR were identified using cardiac catheterization laboratory data. Management for ISR included BA (169 patients), repeat stenting (117 patients), RA (107 patients) or CABG (117 patients). Clinical outcome events of interest included death, myocardial infarction, target vessel revascularization (TVR) and a combined end point of these major adverse cardiovascular events (MACE). Mean follow-up was 19+/-12 months (range = 6 to 61 months)., Results: Patients with ISR treated with repeat stent had significantly larger average post-procedure minimal lumen diameter compared with BA or RA (3.3+/-0.4 mm vs. 3.0+/-0.4 vs. 2.9+/-0.5, respectively, p < 0.05). Incidence of TVR and MACE were similar in the BA, stent and RA groups (39%, 40%, 33% for TVR and 43%, 40%, 33% for MACE, p = NS). Patients with diabetes who underwent RA had similar outcomes as patients without diabetes, while patients with diabetes who underwent BA or stent had worse outcomes than patients without diabetes. Patients who underwent CABG for ISR, mainly because of the presence of multivessel disease, had significantly better outcomes than any percutaneous treatment (8% for TVR and 23% for MACE)., Conclusions: In this large cohort of patients with ISR and in the subset of patients without diabetes, long-term outcomes were similar in the BA, repeat stent and RA groups. Tissue debulking with RA yielded better results only in diabetic patients. Bypass surgery for patients with multivessel disease and ISR provided the best outcomes.
- Published
- 2001
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24. Fibrinolytic monotherapy for acute myocardial infarction.
- Author
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Smalling RW
- Subjects
- Anterior Wall Myocardial Infarction, Humans, Myocardial Infarction drug therapy, Fibrinolytic Agents therapeutic use, Thrombolytic Therapy
- Published
- 2001
25. Successful treatment of coronary artery perforation in an abciximab-treated patient by microcoil embolization.
- Author
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Assali AR, Moustapha A, Sdringola S, Rihner M, and Smalling RW
- Subjects
- Abciximab, Aged, Antibodies, Monoclonal therapeutic use, Humans, Immunoglobulin Fab Fragments therapeutic use, Male, Rupture, Stents, Atherectomy, Coronary adverse effects, Coronary Disease therapy, Coronary Vessels injuries, Embolization, Therapeutic, Platelet Glycoprotein GPIIb-IIIa Complex therapeutic use
- Abstract
We describe a case of type 2 coronary artery perforation in a 73-year-old man undergoing coronary artery rotablation and stenting with abciximab therapy. The coronary artery perforation was successfully treated by coil embolization with Trufill pushable coils made from platinum alloy and synthetic fibers to promote maximum thrombogenicity.
- Published
- 2000
- Full Text
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26. Adenosine use during aortocoronary vein graft interventions reverses but does not prevent the slow-no reflow phenomenon.
- Author
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Sdringola S, Assali A, Ghani M, Yepes A, Rosales O, Schroth GW, Fujise K, Anderson HV, and Smalling RW
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- Aged, Female, Humans, Male, Middle Aged, Prospective Studies, Regional Blood Flow, Retrospective Studies, Treatment Outcome, Adenosine therapeutic use, Coronary Artery Bypass, Coronary Circulation, Postoperative Complications prevention & control, Saphenous Vein transplantation, Vasodilator Agents therapeutic use
- Abstract
Slow or no reflow (SNR) complicates 10-15% of cases of percutaneous intervention (PI) in saphenous vein bypass graft (SVG). To date there have been limited options for the prevention and treatment of this common and potentially serious complication. We evaluated the procedural outcome of 143 consecutive SVG interventions. We compared patients who received pre-intervention intra-graft adenosine boluses with those who did not. In addition we examined the efficacy of adenosine boluses to reverse slow-no reflow events. Angiograms were reviewed and flow graded (TIMI grade) by film readers blinded to the use of any intraprocedural drug or clinical history. Seventy patients received intragraft adenosine boluses before percutaneous intervention (APPI), 73 received no preintervention adenosine (NoAPPI). There were no significant angiographic differences between the two groups at baseline. A total of 20 patients experienced SNR. The incidence of SNR was similar in the two groups (APPI = 14.2% vs. NoAPPI = 13.6%, P = 0.9). SNR was treated with repeated, rapid boluses (24 microg each) of intra-graft adenosine. Reversal of SNR was observed in 10 of 11 patients (91%) who received high doses of adenosine (>/=5 boluses, mean 7.7 +/- 2.6) and in 3 of 9 (33%) of those who received low doses (<5 boluses, mean 1.5 +/- 1.2). Final TIMI flow was significantly better in the high dose than in the low dose group (final TIMI 2.7 +/- 0.6 vs. 2 +/- 0.8, P = 0.04). No significant untoward complications were observed during adenosine infusion. These findings suggest that SNR after PI in SVG is not prevented by pre-intervention adenosine, but it can be safely and effectively reversed by delivery of multiple, rapid and repeated boluses of 24 microg of intra-graft adenosine.
- Published
- 2000
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27. Intracoronary adenosine administered during percutaneous intervention in acute myocardial infarction and reduction in the incidence of "no reflow" phenomenon.
- Author
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Assali AR, Sdringola S, Ghani M, Denkats AE, Yepes A, Hanna GP, Schroth G, Fujise K, Anderson HV, Smalling RW, and Rosales OR
- Subjects
- Adenosine therapeutic use, Adult, Aged, Female, Hospital Mortality, Humans, Male, Middle Aged, Myocardial Infarction mortality, Myocardial Infarction physiopathology, Retrospective Studies, Treatment Outcome, Adenosine administration & dosage, Angioplasty, Balloon, Coronary, Coronary Vessels physiopathology, Myocardial Infarction therapy, Vascular Patency
- Abstract
Percutaneous intervention in acute myocardial infarction has been associated with a high incidence of "no reflow," ranging from 11% to 30%, with an increased risk of complications. The role of intracoronary adenosine for the prevention of this phenomenon has not been evaluated fully. We studied the procedural outcomes of 79 patients who underwent percutaneous intervention in the context of acute myocardial infarction. Twenty-eight patients received no intracoronary adenosine, and 51 received intracoronary adenosine boluses (24-48 microg before and after each balloon inflation). Eight patients who were not given adenosine experienced no reflow (28.6%) and higher rates of in-hospital death, while only three of 51 patients (5.9%; P = 0.014) in the adenosine group experienced no reflow. No untoward complications were noted during adenosine infusion. Intracoronary adenosine bolus administration during percutaneous intervention in the context of acute myocardial infarction is easy and safe and may significantly lessen the incidence of no reflow, which may improve the outcome of this procedure.
- Published
- 2000
- Full Text
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28. Timing of coronary stent thrombosis in patients treated with prophylactic tirofiban.
- Author
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Assali AR, Sdringola S, Ghani M, Westbrook LA, Anderson HV, Schroth G, Fujise K, Smalling RW, and Rosales OR
- Subjects
- Coronary Angiography, Coronary Disease diagnostic imaging, Coronary Disease therapy, Female, Graft Occlusion, Vascular diagnostic imaging, Humans, Male, Middle Aged, Prosthesis Failure, Retrospective Studies, Time Factors, Tirofiban, Angioplasty, Balloon, Coronary instrumentation, Graft Occlusion, Vascular prevention & control, Platelet Aggregation Inhibitors therapeutic use, Platelet Glycoprotein GPIIb-IIIa Complex antagonists & inhibitors, Stents, Tyrosine analogs & derivatives, Tyrosine therapeutic use
- Abstract
Background: Acute and subacute stent thromboses (ASST) are the major thrombotic complications of coronary stenting. The time course of ASST seems to be related to the type of antithrombotic therapy (four days in patients treated with aspirin and coumadin compared to 12 hours with the use of aspirin and ticlopidine). In this report, we compared the timing of ASST in patients treated with aspirin, ticlopidine/clopidogrel, heparin and tirofiban with that in patients treated with the same drugs but without tirofiban., Methods: Retrospective analysis of the Hermann intervention database between January 1997 and October 1999 was performed. We identified 13 patients who required reintervention in the first week after a successful coronary stenting ( 1 stent). Four patients were treated with tirofiban (Group 1) and 9 were not (Group 2)., Results: The median time from stent deployment to ASST was 7 hours (interquartile range, 2.5Eth 33 hours) in group 2 compared to 84.5 hours (interquartile range, 56Eth 124.5 hours) in group 1. The mean time from stent deployment to ASST was 90.3 +/- 43.1 hours in group 1 versus 12.8 +/- 15.3 hours in group 2 (p = 0.0005). All episodes of ASST occurred 3 days in patients treated with tirofiban, whereas they occurred in the first 2 days in all patients not treated with tirofiban., Conclusion: Prophylactic tirofiban treatment delays the time to stent thrombosis after successful coronary artery stent implantation for more than two days. Patients at high risk for stent thrombosis treated with short-acting glycoprotein IIb/IIIa platelet receptor inhibitors may warrant close follow-up during the first week after stenting.
- Published
- 2000
29. Transseptal puncture guided by intracardiac echocardiography during percutaneous transvenous mitral commissurotomy in patients with distorted anatomy of the fossa ovalis.
- Author
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Cafri C, de la Guardia B, Barasch E, Brink J, and Smalling RW
- Subjects
- Aged, Cardiac Catheterization, Female, Heart Septal Defects, Atrial diagnostic imaging, Heart Septum diagnostic imaging, Humans, Male, Mitral Valve Stenosis diagnostic imaging, Catheterization methods, Echocardiography methods, Endosonography, Heart Septal Defects, Atrial complications, Heart Septum surgery, Mitral Valve Stenosis therapy, Punctures
- Abstract
Positioning of the transseptal needle during percutaneous transvenous mitral commissurotomy (PTMV) can become a difficult and risky procedure when distortion of the interatrial septum exists. We present two cases where intracardiac echocardiography (ICE) facilitated the transseptal puncture in the presence of bulging of the fossa ovalis into the right atrium.
- Published
- 2000
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30. Pasta without sauce?
- Author
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Denktas AE and Smalling RW
- Subjects
- Coronary Angiography, Humans, Myocardial Infarction diagnostic imaging, Myocardial Infarction mortality, Platelet Aggregation Inhibitors therapeutic use, Platelet Glycoprotein GPIIb-IIIa Complex antagonists & inhibitors, Secondary Prevention, Thrombolytic Therapy, Treatment Outcome, Angioplasty, Balloon, Coronary, Blood Vessel Prosthesis Implantation, Myocardial Infarction therapy, Stents
- Published
- 1999
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31. Intracoronary adenosine administered during rotational atherectomy of complex lesions in native coronary arteries reduces the incidence of no-reflow phenomenon.
- Author
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Hanna GP, Yhip P, Fujise K, Schroth GW, Rosales OR, Anderson HV, and Smalling RW
- Subjects
- Coronary Angiography, Coronary Artery Disease diagnostic imaging, Coronary Vessels, Female, Humans, Injections, Intra-Arterial, Intraoperative Period, Male, Postoperative Complications epidemiology, Retrospective Studies, Treatment Outcome, Adenosine administration & dosage, Atherectomy, Coronary methods, Coronary Artery Disease surgery, Postoperative Complications prevention & control, Vasodilator Agents administration & dosage
- Abstract
Rotational atherectomy (RA) of complex, calcified lesions has been associated with a high incidence of no reflow ranging from 6%-15% and concomitant myocardial necrosis with adverse prognostic implications. There are no uniform strategies for preventing this complication. The role of intracoronary adenosine for the prevention of this phenomenon during RA has not been fully evaluated. We studied the procedural outcome of 122 patients who underwent RA of complex native coronary artery lesions. Fifty-two patients received no adenosine but a variety of other agents. Seventy patients received intracoronary adenosine boluses (24 to 48 microgram prior to and after each RA run). There was no difference in the type of lesion studied, run time, or Burr to artery ratio (0.6-0.7) between the two groups. Six patients without adenosine experienced no reflow (11.6%), with resultant infarction in the target artery territory, while only 1 of 70 patients (1.4%, P - 0.023) in the adenosine group experienced no reflow. No untoward complications were observed during adenosine infusion. Intracoronary adenosine bolus administered during rotational atherectomy is easy, safe, and may significantly reduce the incidence of no reflow, which may improve the 30-day outcome of this procedure., (Copyright 1999 Wiley-Liss, Inc.)
- Published
- 1999
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32. Primary stenting for acute myocardial infarction.
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Peter J, Yhip A, and Smalling RW
- Subjects
- Acute Disease, Humans, Myocardial Infarction physiopathology, Angioplasty, Balloon, Coronary, Myocardial Infarction therapy, Stents
- Abstract
Primary stenting for acute MI has been shown to be an improvement over PTCA alone. As with primary PTCA however there is an obligate delay in restoration of TIMI flow due to the time necessary for mobilization of the cath lab team. It is possible that a hybrid approach using partial thrombolysis plus early IIB/IIIA inhibitor administration followed by urgent angiography and stenting of the culprit lesion will be the ideal approach.
- Published
- 1999
33. Gastroepiploic bypass graft stenting.
- Author
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Feld S and Smalling RW
- Subjects
- Humans, Molsidomine analogs & derivatives, Molsidomine therapeutic use, Stomach blood supply, Vasodilator Agents therapeutic use, Angina, Unstable therapy, Arteries transplantation, Coronary Artery Bypass, Coronary Disease surgery, Graft Occlusion, Vascular therapy, Stents
- Published
- 1999
- Full Text
- View/download PDF
34. Evaluation of a weight-adjusted single-bolus plasminogen activator in patients with myocardial infarction: a double-blind, randomized angiographic trial of lanoteplase versus alteplase.
- Author
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den Heijer P, Vermeer F, Ambrosioni E, Sadowski Z, López-Sendón JL, von Essen R, Beaufils P, Thadani U, Adgey J, Pierard L, Brinker J, Davies RF, Smalling RW, Wallentin L, Caspi A, Pangerl A, Trickett L, Hauck C, Henry D, and Chew P
- Subjects
- Adolescent, Adult, Aged, Aged, 80 and over, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Male, Middle Aged, Recombinant Proteins therapeutic use, Tissue Plasminogen Activator administration & dosage, Tissue Plasminogen Activator adverse effects, Coronary Angiography, Myocardial Infarction drug therapy, Tissue Plasminogen Activator therapeutic use
- Abstract
Background: Lanoteplase (nPA) is a rationally designed variant of tissue plasminogen activator with greater fibrinolytic potency and slower plasma clearance than alteplase., Methods and Results: InTIME (Intravenous nPA for Treatment of Infarcting Myocardium Early), a multicenter, double-blind, randomized, double-placebo angiographic trial, evaluated the dose-response relationship and safety of single-bolus, weight-adjusted lanoteplase. Patients (n=602) presenting within 6 hours of acute myocardial infarction were randomized and treated with either a single-bolus injection of lanoteplase (15, 30, 60, or 120 kU/kg) or accelerated alteplase. The primary objective was to determine TIMI grade flow at 60 minutes. Angiographic assessments were also performed at 90 minutes and on days 3 to 5. Follow-up was continued for 30 days. Lanoteplase achieved its primary objective, demonstrating a dose-response in TIMI grade 3 flow at 60 minutes (23.6% to 47.1% of subjects, P<0. 001). Similar results were observed at 90 minutes (26.1% to 57.1%, P<0.001). At 90 minutes, coronary patency (TIMI 2 or 3) increased across the dose range up to 83% of subjects at 120 kU/kg lanoteplase compared with 71.4% with alteplase. Thus, at this dose, lanoteplase was superior to alteplase in restoring coronary patency (difference, 12%; 95% CI, 1% to 23%). The early safety experience in this study suggests that lanoteplase was well tolerated at all doses with safety comparable to that of alteplase., Conclusions: Lanoteplase, a single-bolus, weight-adjusted agent, increased coronary patency at 60 and 90 minutes in a dose-dependent fashion. Coronary patency at 90 minutes was achieved more frequently with 120 kU/kg lanoteplase than alteplase. In this study, safety with lanoteplase and alteplase was comparable. InTIME-II, a worldwide mortality trial, will evaluate efficacy and safety with this promising new agent.
- Published
- 1998
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35. Pathophysiological insight into the possible optimal therapies for acute myocardial infarction and unstable angina.
- Author
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Smalling RW and Anderson HV
- Subjects
- Angioplasty, Balloon, Coronary, Coronary Vessels pathology, Humans, Plasminogen Activators therapeutic use, Recombinant Proteins therapeutic use, Thrombolytic Therapy, Tissue Plasminogen Activator therapeutic use, Angina, Unstable pathology, Angina, Unstable therapy, Myocardial Infarction pathology, Myocardial Infarction therapy
- Published
- 1998
- Full Text
- View/download PDF
36. Bubble at tip of the stent delivery system of the Palmaz-Schatz stent improves trackability to the target site.
- Author
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Fujise K, Ganim M, Loyd D, Schroth G, and Smalling RW
- Subjects
- Equipment Design, Humans, Catheterization, Coronary Vessels, Stents
- Published
- 1998
- Full Text
- View/download PDF
37. A fresh look at the molecular pharmacology of plasminogen activators: from theory to test tube to clinical outcomes.
- Author
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Smalling RW
- Subjects
- Animals, Fibrinolysin metabolism, Humans, Myocardial Infarction drug therapy, Plasminogen metabolism, Plasminogen Activators therapeutic use, Recombinant Proteins pharmacology, Recombinant Proteins therapeutic use, Streptokinase pharmacology, Streptokinase therapeutic use, Tissue Plasminogen Activator pharmacology, Tissue Plasminogen Activator therapeutic use, Plasminogen Activators pharmacology, Thrombolytic Therapy
- Abstract
The molecular pharmacology of plasminogen activators and its implications for thrombolytic therapy are discussed. The benefits of coronary thrombolysis were first demonstrated with intracoronary and i.v. streptokinase. Tissue plasminogen activator (t-PA) or recombinant t-PA (alteplase) proved to be superior to streptokinase with respect to speed of reperfusion and reperfusion efficacy. Since alteplase neither lessened the risk of bleeding found with streptokinase nor generated Thrombolysis in Myocardial Infarction (TIMI) grade 3 flow rates above about 50%, the quest for faster-acting, safer, and more effective thrombolytic agents has continued. The ideal agent would be highly efficient at converting plasminogen to plasmin, have an intermediate half-life, have a low affinity for fibrin, and be of reasonable cost. Genetic engineering of the wild-type t-PA molecule resulted in reteplase, which has a longer half-life than alteplase and may be superior in terms of lytic activity, myocardial salvage, and survival. Also under investigation are TNK-t-PA and n-PA, which have longer half-lives and, in animal models, seem to produce more rapid and complete thrombolysis, at less risk of intracranial bleeding, than alteplase. The risk of intracranial bleeding remains a problem with all thrombolytics; the risk versus the benefit will have to be assessed in large randomized trials. An understanding of the functions of various regions of the t-PA molecule has led to genetic engineering of new and promising plasminogen activators.
- Published
- 1997
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38. Infrapopliteal transcatheter interventions for limb salvage in diabetic patients: importance of aggressive interventional approach and role of transcutaneous oximetry.
- Author
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Hanna GP, Fujise K, Kjellgren O, Feld S, Fife C, Schroth G, Clanton T, Anderson V, and Smalling RW
- Subjects
- Angiography, Blood Pressure, Brachial Artery physiopathology, Diabetic Foot blood, Female, Humans, Ischemia blood, Male, Middle Aged, Peripheral Vascular Diseases blood, Peripheral Vascular Diseases therapy, Prognosis, Treatment Outcome, Angioplasty, Balloon, Blood Gas Monitoring, Transcutaneous, Diabetic Foot therapy, Ischemia therapy, Leg blood supply, Popliteal Artery
- Abstract
Objectives: This study sought to determine whether infrapopliteal transcatheter interventions can salvage ischemic limbs in diabetic patients referred for below the knee amputation at our institution., Background: The value of transcatheter interventions in diabetic crural arteries is controversial. Tissue oxygen partial pressure (TCO2) levels < 40 mm Hg predict poor wound healing., Methods: Percutaneous interventions were performed in 29 consecutive diabetic patients in need of limb salvage. Technical success was defined as < 20% residual vessel stenosis. Clinical success was defined as the avoidance of amputation and achievement of wound healing. At hospital discharge, patients were treated with Coumadin and aspirin. Ankle-brachial index (ABI) and TCO2 measurements were obtained before and after the intervention., Results: After 12-month follow-up, six patients had presistent wounds, whereas 23 experienced wound healing. Forty of the 50 infrapopliteal arteries successfully dilated were occluded, with a mean (+/-SD) lesion length of 18.0 +/- 3.5 cm. After the procedure, TCO2 improved from 27.82 +/- 9.97 mm Hg (95% confidence interval [CI] 23.95 to 31.69) to 54.5 +/- 14.73 mm Hg (95% CI 48.79 to 60.21, p < 0.0001), whereas the ABI did not (p > 0.2). TCO2 predicted procedural and clinical success (p < 0.0182)., Conclusions: Infrapopliteal transcatheter interventions in diabetic patients may salvage the majority of limbs doomed to amputation. Although TCO2 measurements are valuable in predicting wound healing and success after interventions, ABI measurements are not.
- Published
- 1997
- Full Text
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39. Reteplase (r-PA): a new plasminogen activator.
- Author
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Bode C, Kohler B, Moser M, Schmittner M, Smalling RW, and Strasser RH
- Abstract
Reteplase (r-PA) is a genetically engineered deletion mutant of wild-type tissue-type plasminogen activator. The structural differences lead to different functional properties, such as a prolonged half-life. The compound demonstrated good thrombolytic efficacy in in vitro as well as in animal studies. In angiographically controlled patency studies (GRECO, GRECO-2 RAPID-1, RAPID-2), the double-bolus application scheme was established, and a superior patency profile for reteplase in comparison to alteplase was demonstrated. Mortality studies established reteplase as a safe drug with a 30-day mortality at least equivalent to streptokinase (INJECT) and very similar to alteplase (GUSTO-3). A possible advantage may be the double-bolus application without a need for weight adjustment, especially in a prehospital setting. Thus, reteplase can be regarded as an excellent alternative to streptokinase or alteplase for thrombolytic therapy in acute myocardial infarction.
- Published
- 1997
- Full Text
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40. Coronary AVE micro stents: do we need another stent?
- Author
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Ganim MS and Smalling RW
- Subjects
- Animals, Humans, Angioplasty, Balloon, Coronary, Stents
- Published
- 1997
- Full Text
- View/download PDF
41. Patency trials with reteplase (r-PA): what do they tell us?
- Author
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Bode C, Nordt TK, Peter K, Smalling RW, Runge MS, and Kübler W
- Subjects
- Cerebral Hemorrhage chemically induced, Clinical Trials, Phase II as Topic, Coronary Circulation, Coronary Vessels drug effects, Coronary Vessels pathology, Drug Administration Schedule, Fibrinolytic Agents administration & dosage, Fibrinolytic Agents adverse effects, Hemorrhage chemically induced, Humans, Incidence, Myocardial Infarction drug therapy, Myocardial Infarction pathology, Plasminogen Activators administration & dosage, Plasminogen Activators adverse effects, Recombinant Proteins administration & dosage, Recombinant Proteins adverse effects, Recombinant Proteins therapeutic use, Survival Rate, Tissue Plasminogen Activator administration & dosage, Tissue Plasminogen Activator adverse effects, Tissue Plasminogen Activator therapeutic use, Treatment Outcome, Vascular Patency drug effects, Fibrinolytic Agents therapeutic use, Plasminogen Activators therapeutic use, Randomized Controlled Trials as Topic, Thrombolytic Therapy
- Abstract
Thrombolytic therapy has been shown to reduce mortality and morbidity after acute myocardial infarction. Therapeutic benefit seems to be directly correlated with completeness of reperfusion (Thrombolysis in Myocardial Infarction [TIMI] grade 3 flow) of the infarct-related coronary artery, as well as the timeliness of reperfusion. To determine which regimen of reteplase (r-PA), a deletion mutant of wild-type tissue plasminogen activator (t-PA), is most effective for clinical thrombolysis, several reteplase regimens were compared with the most successful standard regimens of recombinant t-PA (alteplase) in 2 large-scale, randomized studies. All patients received aspirin and intravenous heparin. In the Reteplase Angiographic Phase II International Dose Finding Trial (RAPID-1), results in 606 randomized patients showed that a 10 + 10 U double bolus of reteplase was more effective than a 15 U single bolus, a 10 + 5 double bolus, or conventional alteplase (100 mg over 3 hours). In the Reteplase versus Alteplase Patency Investigation During Acute Myocardial Infarction (RAPID-2) trial, results in 324 patients showed that significantly more patients achieved patency of the infarct-related artery (TIMI grade 2 or 3 flow) at 90 minutes with reteplase (10 + 10 U double bolus) than with accelerated alteplase (100 mg over 90 minutes): 83.4% versus 73.3%, respectively (p = 0.03). The incidence of complete patency (TIMI grade 3 flow) at 90 minutes was likewise greater with reteplase than with accelerated alteplase (59.9% vs 45.2%, respectively; p = 0.01). At 60 minutes, the incidence of TIMI grade 2 or 3 flow was also significantly higher with reteplase than with alteplase (81.8% vs 66.1%, respectively; p = 0.01), as was the incidence of TIMI grade 3 flow (51.2% vs 37.4%, respectively; p < 0.031). The 35-day mortality rate was 4.1% for reteplase and 8.4% for alteplase (p = not significant). Reteplase and alteplase did not differ significantly with regard to the occurrence of severe bleeding (12.4% vs 9.7%, respectively) or hemorrhagic stroke (1.2% vs 1.9%, respectively). The results of these trials show that reteplase, given as a 10 + 10 U double bolus, achieves significantly higher rates of early reperfusion of the infarct-related coronary artery and is associated with significantly fewer acute coronary interventions when compared with front-loaded alteplase. The benefits of reteplase are achieved without any apparent increased risk of complications.
- Published
- 1996
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- View/download PDF
42. Molecular biology of plasminogen activators: what are the clinical implications of drug design?
- Author
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Smalling RW
- Subjects
- Animals, Cerebral Hemorrhage etiology, Disease Models, Animal, Drug Administration Schedule, Drug Design, Half-Life, Hemorrhage chemically induced, Humans, Molecular Biology, Myocardial Infarction drug therapy, Myocardial Reperfusion, Plasminogen Activators administration & dosage, Plasminogen Activators genetics, Plasminogen Activators pharmacokinetics, Plasminogen Activators therapeutic use, Point Mutation genetics, Recombinant Proteins chemistry, Recombinant Proteins pharmacokinetics, Recombinant Proteins therapeutic use, Risk Factors, Streptokinase administration & dosage, Streptokinase therapeutic use, Survival Rate, Tissue Plasminogen Activator administration & dosage, Tissue Plasminogen Activator chemistry, Tissue Plasminogen Activator genetics, Tissue Plasminogen Activator therapeutic use, Plasminogen Activators chemistry, Thrombolytic Therapy
- Abstract
The initial work on thrombolytic therapy for acute myocardial infarction (AMI) focused on intracoronary administration of streptokinase. Continuing research has given rise to the development of both second- and third-generation agents and consequent refinements in thrombolytic regimens. Intravenous recombinant tissue plasminogen activator (t-PA, or alteplase) proved superior to both intracoronary and intravenous streptokinase with regard to reperfusion efficacy and impact on survival. An accelerated dosage regimen was later devised to allow the administration of t-PA over a shorter period of time. Unfortunately, t-PA failed to lessen the risk of bleeding complications that had plagued the use of streptokinase. The wild-type t-PA molecule has since been modified in an attempt to achieve improved lytic characteristics with less bleeding risk. Among these third-generation agents is reteplase (r-PA); compared with alteplase, reteplase has a prolonged half-life and seems to offer more rapid thrombolysis. Promising results have been obtained in large, randomized trials of reteplase. Another new agent is the TNK mutant of t-PA, which also has a prolonged half-life and seems to produce more rapid and complete thrombolysis, as well as less risk of intracranial bleeding than with alteplase in animal models. Although large, randomized trials have not yet been conducted, encouraging results have emerged from preliminary dose-ranging trials with TNK. A third new agent, n-PA, has an even longer half-life and has shown improved lytic activity in animal models. A dose-ranging trial of n-PA is currently under way. Despite the fact that each of the third-generation drugs has shown considerable potential with regard to improving the efficacy of thrombolytic therapy, the risk of intracranial bleeding remains problematic and will need to be assessed in large, randomized trials.
- Published
- 1996
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43. Reduction of canine infarct size by bolus intravenous administration of liposomal prostaglandin E1: comparison with control, placebo liposomes, and continuous intravenous infusion of prostaglandin E1.
- Author
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Feld S, Li G, Wu A, Felli P, Amirian J, Vaughn WK, Gornet T, Swenson C, and Smalling RW
- Subjects
- Alprostadil therapeutic use, Animals, Collateral Circulation physiology, Coronary Circulation physiology, Dogs, Drug Carriers, Infusions, Intravenous, Injections, Intravenous, Liposomes, Myocardial Infarction physiopathology, Neutrophil Activation drug effects, Peroxidase metabolism, Time Factors, Vasodilator Agents therapeutic use, Alprostadil administration & dosage, Myocardial Infarction drug therapy, Vasodilator Agents administration & dosage
- Abstract
Prostaglandin E1 (PGE1) reduces experimental infarct size when administered by prolonged low-dose left atrial infusion during coronary occlusion. Liposomal delivery of PGE1 may enhance biologic activity and limit adverse hemodynamic effects. The purpose of this study was to test the hypothesis that intravenous bolus administration of liposomal PGE1 (TLC C-53, The Liposome Company, Princeton, N.J.) during coronary occlusion would result in myocardial salvage. We compared TLC C-53 (0.5 microgram/kg intravenous bolus at 10 and 100 min of occlusion of the left anterior descending coronary artery [LAD]), free PGE1 (0.1 microgram/kg/min infused 10 min after LAD occlusion until reperfusion), placebo liposomes, and control (n = 7 for each group) in an open-chest canine model of 2 hours of LAD occlusion and reperfusion. Infarct size as a percentage of risk area (mean +/- SD) in the control group (58.4% +/- 20.0%) was similar to that in animals given placebo liposomes (53.1% +/- 12.6%) but was significantly reduced in the groups given TLC C-53 (33.5% +/- 9.2%; p < 0.01) or free PGE1 (37.2% +/- 4.8%; p < 0.05) groups. Infarct salvage was significant (p < 0.05) for the TLC C-53-and PGE1-treated dogs compared with the control dogs, independent of collateral blood flow by analysis of covariance. Moreover, the ischemic-zone blood flow during reperfusion was significantly higher in the TLC C-53 group compared with the control group or the group receiving free PGE1. Neutrophil infiltration of ischemic myocardium was significantly inhibited by TLC C-53 as determined by myeloperoxidase assay. Unlike free PGE1, TLC C-53 did not cause significant tachycardia or hypotension during therapy. In conclusion, TLC C-53 administered intravenously during coronary occlusion significantly reduced infarct size, limited neutrophil infiltration, and improved myocardial blood flow during reperfusion without adverse hemodynamic consequences.
- Published
- 1996
- Full Text
- View/download PDF
44. Randomized comparison of coronary thrombolysis achieved with double-bolus reteplase (recombinant plasminogen activator) and front-loaded, accelerated alteplase (recombinant tissue plasminogen activator) in patients with acute myocardial infarction. The RAPID II Investigators.
- Author
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Bode C, Smalling RW, Berg G, Burnett C, Lorch G, Kalbfleisch JM, Chernoff R, Christie LG, Feldman RL, Seals AA, and Weaver WD
- Subjects
- Adult, Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, Plasminogen Activators adverse effects, Recombinant Proteins adverse effects, Recombinant Proteins therapeutic use, Tissue Plasminogen Activator adverse effects, Coronary Thrombosis drug therapy, Fibrinolytic Agents therapeutic use, Myocardial Infarction drug therapy, Plasminogen Activators therapeutic use, Tissue Plasminogen Activator therapeutic use
- Abstract
Background: The therapeutic benefit of thrombolytic therapy has been shown to correlate directly with completeness (TIMI grade 3 flow) and speed of reperfusion of the infarct-related coronary artery. The purpose of the RAPID II study was to determine whether a double-bolus regimen of reteplase, a recently developed deletion mutant of wild-type tissue plasminogen activator, could improve 90-minute coronary artery patency rates achieved with the most successful standard regimen, an "accelerated" front-loaded infusion of alteplase., Methods and Results: Three hundred twenty-four patients with acute myocardial infarction were randomized to receive (along with intravenous heparin and aspirin) either a 10 plus 10 megaunits double bolus of reteplase or front-loaded alteplase. The primary end point of "patency at 90 minutes, graded according to the TIMI classification" was centrally assessed in a blinded fashion. Infarctrelated coronary artery patency (TIMI grade 2 or 3) and complete patency (TIMI grade 3) at 90 minutes after the start of thrombolytic therapy were significantly higher in the reteplase-treated patients (TIMI grade 2 or 3: 83.4% versus 73.3% for front-loaded alteplase-treated patients, P = .03; TIMI grade 3: 59.9% versus 45.2%, P = .01). At 60 minutes, the incidence of both, patency and complete patency, was also significantly higher in reteplase-treated patients (reteplase versus alteplase, TIMI grade 2 or 3: 81.8% versus 66.1%, P = .01; TIMI grade 3: 51.2% versus 37.4%, P < .03). Reteplase-treated patients required fewer acute additional coronary interventions (13.6% versus 26.5%, P < .01), and 35-day mortality was 4.1% for reteplase and 8.4% for alteplase (P = NS). There were no significant differences between reteplase and alteplase in bleedings requiring a transfusion (12.4% versus 9.7%) or hemorrhagic stroke (1.2% versus 1.9%)., Conclusions: Reteplase, when given as a double bolus of 10 plus 10 megaunits to patients with acute myocardial infarction, achieves significantly higher rates of early reperfusion of the infarct-related coronary artery and requires significantly fewer acute coronary interventions than front-loaded alteplase without an apparent increased risk of complications.
- Published
- 1996
- Full Text
- View/download PDF
45. Comparison of angioscopy, intravascular ultrasound imaging and quantitative coronary angiography in predicting clinical outcome after coronary intervention in high risk patients.
- Author
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Feld S, Ganim M, Carell ES, Kjellgren O, Kirkeeide RL, Vaughn WK, Kelly R, McGhie AI, Kramer N, Loyd D, Anderson HV, Schroth G, and Smalling RW
- Subjects
- Angioplasty, Balloon, Coronary, Angioplasty, Balloon, Laser-Assisted, Angioscopy, Atherectomy, Coronary, Cohort Studies, Coronary Angiography methods, Coronary Disease epidemiology, Disease-Free Survival, Female, Humans, Male, Middle Aged, Predictive Value of Tests, Retrospective Studies, Risk Factors, Stents, Time Factors, Treatment Outcome, Ultrasonography, Interventional, Coronary Disease diagnosis, Coronary Disease therapy
- Abstract
Objectives: The purpose of this study was to identify qualitative or quantitative variables present on angioscopy, intravascular ultrasound imaging or quantitative coronary arteriography that were associated with adverse clinical outcome after coronary intervention in high risk patients., Background: Patients with acute coronary syndromes and complex lesion morphology on angiography are at increased risk for acute complications after coronary angioplasty. Newer devices that primarily remove atheroma have not improved outcome over that of balloon angioplasty. Intravascular imaging can accurately identify intraluminal and intramural histopathologic features not adequately visualized during coronary arteriography and may provide mechanistic insight into the pathogenesis of abrupt closure and restenosis., Methods: Sixty high risk patients with unstable coronary syndromes and complex lesions on angiography underwent angioscopy (n = 40) and intravascular ultrasound imaging (n = 46) during interventional procedures. In 26 patients, both angioscopy and intravascular ultrasound were performed in the same lesion. All patients underwent off-line quantitative coronary arteriography. Coronary interventions included balloon (n = 21) and excimer laser (n = 4) angioplasty, directional (n = 19) and rotational (n = 6) atherectomy and stent implantation (n = 11). Patients were followed up for 1 year for objective evidence for recurrent ischemia., Results: Patients whose clinical presentation included rest angina or acute myocardial infarction or who received thrombolytic therapy within 24 h of procedure were significantly more likely to experience recurrent ischemia after intervention. Plaque rupture or thrombus on preprocedure angioscopy or angioscopic thrombus after intervention were also significantly associated with adverse outcome. Qualitative or quantitative variables on angiography, intravascular ultrasound or off-line quantitative arteriography were not associated with recurrent ischemia on univariate analysis. Multivariate predictors of recurrent ischemia were plaque rupture on preprocedure angioscopy (p < 0.05, odds ratio [OR] 10.15) and angioscopic thrombus after intervention (p < 0.05, OR 7.26)., Conclusions: Angioscopic plaque rupture and thrombus were independently associated with adverse outcome in patients with complex lesions after interventional procedures. These features were not identified by either angiography or intravascular ultrasound.
- Published
- 1996
- Full Text
- View/download PDF
46. Rotational atherectomy with a new device: initial clinical experience.
- Author
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Kjellgren O, Motarjeme A, Feld S, Mishkel DC, Underwood C, Kirkeeide RL, and Smalling RW
- Subjects
- Angioplasty, Balloon instrumentation, Arteriosclerosis diagnostic imaging, Equipment Design, Follow-Up Studies, Humans, Intermittent Claudication diagnostic imaging, Ischemia diagnostic imaging, Postoperative Complications diagnostic imaging, Postoperative Complications therapy, Radiography, Recurrence, Arteriosclerosis surgery, Atherectomy, Coronary instrumentation, Intermittent Claudication surgery, Ischemia surgery, Leg blood supply
- Abstract
The Bard Atherectomy Catheter is a new rotational atherectomy device that consists of a flexible, hollow, thin-walled cutting catheter that, while rotated at 1,500 revolutions per minute, is advanced across the lesion over a special spiral guidewire system. We report the initial clinical experience with this device in 20 peripheral lesions in ten patients. The majority of patients were treated for limb salvage. All lesions were successfully intervened on by atherectomy followed by adjunctive balloon angioplasty. A reduction to less than 50% stenosis was achieved in 13 of the 20 lesions (65%) after atherectomy but in all 20 lesions (100%) after adjunctive angioplasty for all lesions and stenting for dissections in two. Baseline minimal lesion lumen diameter was 0.8 +/- 0.7 mm with a reference vessel diameter of 4.2 +/- 1.7 mm (75 +/- 21% stenosis). The lumen improved to 2.0 +/- 0.8 mm (45 +/- 19% stenosis) (P < 0.001) following atherectomy and to 3.9 +/- 1.9 mm (13 +/- 16% stenosis) (P < 0.001) after adjunctive angioplasty. The average weight of removed atheroma was 45 +/- 58 mg. All ten patients had initial improvement in symptoms. At 6 months follow-up there was persistent improvement in eight patients and two subjects had undergone amputations. Our early clinical experience with this low profile, flexible atherectomy device, that enables extraction of a large amount of atheroma, suggests that it will become a valuable addition to current atherectomy technologies in small- and medium-sized vessels. The value of this device in coronary vessels is under investigation.
- Published
- 1996
- Full Text
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47. Coronary thrombi increase PTCA risk. Angioscopy as a clinical tool.
- Author
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White CJ, Ramee SR, Collins TJ, Escobar AE, Karsan A, Shaw D, Jain SP, Bass TA, Heuser RR, Teirstein PS, Bonan R, Walter PD, and Smalling RW
- Subjects
- Adult, Aged, Aged, 80 and over, Angioscopy, Coronary Thrombosis diagnosis, Female, Humans, Male, Middle Aged, Risk, Angioplasty, Balloon, Coronary adverse effects, Coronary Thrombosis complications
- Abstract
Background: The presence of angiographically identified intracoronary thrombus has been variably associated with complications after coronary angioplasty. Angiography has been shown to be less sensitive than angioscopy for detecting subtle details of intracoronary morphology, such as intracoronary thrombi. The clinical importance of thrombi detectable by angioscopy but not by angiography is not known., Methods and Results: Percutaneous coronary angioscopy was performed in 122 patients undergoing conventional coronary balloon angioplasty (PTCA) at six medical centers. Unstable angina was present in 95 patients (78%) and stable angina in 27 (22%). Therapy was not guided by angioscopic findings, and no patient received thrombolytic therapy as an adjunct to angioplasty. Coronary thrombi were identified in 74 target lesions (61%) by angioscopy versus only 24 (20%) by angiography. A major in-hospital complication (death, myocardial infarction, or emergency bypass surgery) occurred in 10 of 74 patients (14%) with angioscopic intracoronary thrombus, compared with only 1 of 48 patients (2%) without thrombi (P = .03). In-hospital recurrent ischemia (recurrent angina, repeat PTCA, or abrupt occlusion) occurred in 19 of 74 patients (26%) with angioscopic intracoronary thrombi versus only 5 of 48 (10%) without thrombi (P = .03). Relative risk analysis demonstrated that angioscopic thrombus was strongly associated with adverse outcomes (either a major complication or a recurrent ischemic event) after PTCA (relative risk, 3.11; 95% CI, 1.28 to 7.60; P = .01) and that angiographic thrombi were not associated with these complications (relative risk, 0.85; 95% CI, 0.36 to 2.00; P = .91)., Conclusions: The presence of intracoronary thrombus associated with coronary stenoses is significantly underestimated by angiography. Angioscopic intracoronary thrombi, the majority of which were not detected by angiography, are associated with an increased incidence of adverse outcomes after coronary angioplasty.
- Published
- 1996
- Full Text
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48. Diffuse vasospasm following stenting of a free gastroepiploic artery graft: resolution with balloon angioplasty and intensive medical therapy.
- Author
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Feld S, Kjellgren O, Sweeney MS, Drtil A, Anderson HV, Schroth G, Tauss N, Taegtmeyer H, and Smalling RW
- Subjects
- Coronary Artery Bypass methods, Coronary Vasospasm complications, Female, Graft Occlusion, Vascular etiology, Humans, Middle Aged, Stents, Angioplasty, Balloon, Coronary, Coronary Vasospasm therapy, Graft Occlusion, Vascular therapy
- Abstract
Vasospasm following balloon angioplasty of gastroepiploic artery bypass grafts can be prevented or reversed with vasodilators. In our patient, stent deployment for ostial stenosis of a free gastroepiploic artery graft was accompanied by severe, diffuse spasm and a change in graft configuration that required both intensive medical therapy and balloon angioplasty for resolution.
- Published
- 1995
- Full Text
- View/download PDF
49. Successful treatment of chronic total peripheral occlusions that failed conventional techniques using the stiff backend of the Glidewire.
- Author
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Kjellgren O, Feld S, Loyd D, Schroth G, Anderson HV, and Smalling RW
- Subjects
- Aged, Female, Humans, Male, Peripheral Vascular Diseases diagnostic imaging, Radiography, Angioplasty, Balloon instrumentation, Peripheral Vascular Diseases therapy
- Abstract
The vast majority of failures of transcatheter interventions in patients with peripheral vascular disease are due to inability to cross the lesion with a guidewire. Although the use of the Glidewire has clearly improved the success rate, failures with especially chronic total occlusions still occur. We describe a new technique using the very stiff backend of the Glidewire, which we have found very successful, when conventional techniques fall in crossing highly resistant lesions.
- Published
- 1995
- Full Text
- View/download PDF
50. Infarct salvage with liposomal prostaglandin E1 administered by intravenous bolus immediately before reperfusion in a canine infarction-reperfusion model.
- Author
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Smalling RW, Feld S, Ramanna N, Amirian J, Felli P, Vaughn WK, Swenson C, and Janoff A
- Subjects
- Alprostadil pharmacology, Animals, Cell Movement drug effects, Coronary Circulation drug effects, Dogs, Drug Carriers, Hemodynamics drug effects, Injections, Intravenous, Leukocytes drug effects, Leukocytes physiology, Liposomes, Myocardial Reperfusion Injury pathology, Myocardium pathology, Ventricular Function, Left drug effects, Alprostadil administration & dosage, Myocardial Infarction drug therapy, Myocardial Infarction pathology, Myocardial Reperfusion
- Abstract
Background: Prostaglandin E1 (PGE1) inhibits leukocyte and platelet function and reduces infarct size during left atrial infusion. Intravenous liposomal PGE1 (TLC C-53) accelerates thrombolysis and prevents reocclusion in canine coronary thrombosis. We tested the hypothesis that intravenous TLC C-53 would attenuate reperfusion injury in a canine infarction-reperfusion model., Methods and Results: Twenty-one open-chest dogs were randomized to receive a 10-minute intravenous infusion of either liposome diluent (placebo), free PGE1 (2 micrograms/kg), or TLC C-53 (2 micrograms/kg PGE1) after 2 hours of left anterior descending (LAD) occlusion just before reperfusion. Hemodynamic assessment, regional myocardial blood flow determination with radioactive microspheres, myocardial leukocyte infiltration by myeloperoxidase assay, and estimation of infarct size using triphenyl tetrazolium chloride staining were performed. Regional fractional shortening was measured with sonomicrometer crystals implanted in the midmyocardium. Infarct size as a percentage of the risk region was significantly reduced (P < .05) with TLC C-53 (37.9 +/- 17.4%) compared with PGE1 (56.7 +/- 13.9%) or placebo (58.0 +/- 9.9%) infusion. Infarct salvage with TLC C-53 was independent of collateral blood flow by ANCOVA. There was a dramatic reduction in myeloperoxidase activity in the infarct, risk, and border regions of dogs treated with TLC C-53 compared with placebo. Enzyme activity was also significantly reduced (P < .05) in the infarct zone with TLC C-53 (0.11 +/- 0.1 U/100 mg) treatment compared with PGE1 (0.38 +/- 0.3 U/100 mg). No significant differences in regional myocardial blood flow or myocardial function among treatment groups were identified, although there was a trend toward improved function in the TLC C-53 dogs., Conclusions: Bolus intravenous administration of TLC C-53 immediately before reperfusion results in reduced leukocyte infiltration and substantial infarct salvage. TLC C-53 mah be useful in limiting reperfusion injury during treatment of acute myocardial infarction.
- Published
- 1995
- Full Text
- View/download PDF
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